CN102573949A

CN102573949A - Flexible and conformal patch pump

Info

Publication number: CN102573949A
Application number: CN2010800459065A
Authority: CN
Inventors: G·瑟尔; K·克纳普; P·斯库特尼克; A·皮特里; D·内尔逊; P·布朗
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2009-09-02
Filing date: 2010-09-01
Publication date: 2012-07-11
Anticipated expiration: 2030-09-01
Also published as: EP2473215B1; US20210308367A1; ES2766956T3; US20110054285A1; JP2016055205A; US11744937B2; JP2015051304A; JP2013503692A; EP3616737A2; CA2772594C; JP6224745B2; EP2473215A1; JP5763641B2; CA2772594A1; JP5977317B2; EP3616737A3; US11052189B2; WO2011028279A1; CA3013081A1; US10092691B2

Abstract

Provided is a flexible and conformal wearable, self-contained medical device. The medical device comprises an integral housing formed by a flexible upper portion and a flexible lower portion joined along their perimeters. The medical device is also provided in a plurality of shapes and configurations for increasing the flexibility and conformability of the housing. The components contained within the housing, such as a drug reservoir, printed circuit board, and power supply are preferably constructed from flexible materials and are formed, connected and positioned according to the configuration of the housing in a manner for enhancing flexibility of the housing. A thermal bubble micropump is provided for controlling flow of a drug from the flexible reservoir, that utilizes a thermal resistor provided locally to a thermal expansion fluid that causes a surrounding membrane to expand and displace a volume of drug to be provided to the user.

Description

Flexible and be obedient to sticking type pump

Technical field

The present invention relates to wearable on the whole and holds the infusion device of medicine certainly, in said infusion device is arranged on thorough, the flexible and housing of being obedient to be used for providing the easy property and the captivation of bigger comfortableness, convenience, use to user.

Background technology

Diabetes are to be one group of disease of sign with hyperglycemia level (effect of its generation owing to insulin, insulin or the two defective cause).There is the population of 2,360 ten thousand people or 8% to suffer from diabetes in the U.S..Since the time period of 2005-2007, the total incidence of diabetes has increased by 13.5%.Diabetes can cause severe complications and premature dead, but exist the hit product that can be used for diabetics to help control disease and the risk that reduces complication.

The therapeutic scheme of diabetics comprises specific diet, oral drugs and/or insulinize.The primary goal of treating diabetes is the chance of control patient's blood glucose (sugar) level with the no complication life of raising.But, when taking into account other life requirements and situation, reach good diabetes improvement and always be not easy to.

At present, exist two kinds of main being used to treat the daily insulinize pattern of type i diabetes.First pattern comprises syringe and novopen, and it needs pinprick when per injection (typically be every day three to four times), but be to use simple and cost lower.The diabetes that are used to another kind administer extensively adopt and the efficacious therapy method is to use insulin pump.Insulin pump can help user that their blood sugar level is remained in the target zone through the continuous infusion insulin based on the independent demand of user.Through using insulin pump, user can make their insulinize be matched with their life style, rather than makes their life style be matched with injection of insulin how they to be acted on.

The insulin regular pump can be carried fast or the insulin of part-time application through placing the conduit below the skin 24 hours every days.The dosage of insulin is typically implemented with basic speed and with single dose.Basal insulin 24 hours is carried continuously, and as possible between diet with night the blood sugar level with a people remain in the consistent scope.Some insulin pumps can be programmed to the basic speed of insulin and changed with the different time according to daytime and night.Single dose is typically implemented when user is taken food, and the carbohydrate of the other injection of insulin of single so that balance was consumed is provided usually.Some insulin regular pumps allow that user programmes to the amount of single dose according to the amount or the type of consumption diet.The insulin regular pump allows that also user obtains the insulin single dose proofreading and correct or replenish with compensation hypoglycemia level when user calculates diet dosage.

The insulin regular pump has lot of advantages than other diabetes remedies.Insulin pump is carried insulin along with the time rather than in single injection, and typically causes less changing in the range of blood sugar that ADA is recommended thus.The insulin regular pump reduces the pinprick number of times that patient must stand, and the improvement that for user, makes diabetes more easily and more effective, the quality of life of improving user thus significantly.But insulin pump maybe be heavy and uses loaded down with trivial details, and typically more expensive than other treatment method.From the angle of life style, conventional pump, pipe fitting and infusion device is inconvenience for user and bothers.

The new development of insulinize provides " wearable " drug infusion pumps, sticking type pump for example, and it is lower and use more convenient and more comfortable to a certain extent on cost than insulin regular pump.In these devices some mean part or all disposable, and the advantage that a lot of insulin regular pumps have is provided in theory and does not have the initial expensive and inconvenience of insulin regular pump.But, common sticking type pump not yet to user provide maximum comfortableness with convenience so that itself is by use more widely.Typical sticking type pump is still heavier and volume is bigger, and is configured to have the stiff case that holds rigid element usually, causes the discomfort of user after long-time the use thus.These sticking type pumps often are uncomfortable especially for child, little chap women and old man, and sticking type pump bigger for them is unfavorable.In addition, the structure of common sticking type pump stops the sticking type pump to be covered and limited the number of positions that on the health of user, can dress the sticking type pump easily.

Therefore, have the demand for following more thorough drug infusion pumps: it has improved convenience, comfortableness and wearable property, makes more user possibly benefit from the advantage that these devices are provided.

Summary of the invention

Example embodiment of the present invention addresses the above problem and/or shortcoming at least, and following advantage is provided at least.Therefore, the purpose of some embodiment of the present invention provide more thorough, flexible and be obedient to, wearable drug infusion pumps to be to be used for when using this device, improving the convenience and the comfortableness of user.

According to an aspect of the present invention; Be provided for comprising: integral housing to the wearable medical treatment device of user enforcement Drug therapy; Said integral housing comprises the flexible reservoir of the supply that is used for ccontaining medicine, and said flexible reservoir is communicated with the infusion cannula fluid that is used for to user conveying medicine; And apparatus for metering fluids, said apparatus for metering fluids is used to measure from said reservoir through the drug conveying of said infusion cannula to user, and wherein, said housing comprises along periphery sonic welded flexible upper together separately and dividing and flexible lower part.The said top and the said lower part of said housing are made up of flexible polymer; Wherein, The thickness of said integral housing preferably is not more than about 0.75 inch in 0.25 inch to 1.25 inches scope, and is attached to the skin of user through adhesive layer.Froth bed or elastomer layer also can be set to be clipped between the said lower part of said adhesive layer and said medical treatment device.Said apparatus for metering fluids comprises at least one thermal resistance that is arranged at partly in the thermal expansion fluid of being sealed by flexible membrane; Wherein, The fluidic heating of said thermal expansion causes the expansion of said flexible membrane, thereby causes the displacement of medicine and through said infusion needle said medicine is actuated in the said user body.In one embodiment, a plurality of thermal resistances with expansion fluid and flexible membrane can be set in order, flow to the linear peristaltic formula of user to generate said medicine.Said apparatus for metering fluids also comprises and is used to promote medicine to mobile at least one one way stop peturn valve of said user.Said apparatus for metering fluids can also comprise and is used to control medicine to mobile electric controlled door of said user or electrically-controlled valve.In one embodiment, said apparatus for metering fluids alternately comprises a kind of in Bei Shi (Belleville) spring washer, punching press leaf spring, chuck or the flexing part, to be used for discharging medicine from said reservoir.Said medical treatment device also comprises flexible PCB, and said flexible PCB is provided with at least one groove that extends internally from the outward flange of said circuit board, to be used for that fluid metering mechanism is electrically connected with controller.

According to this aspect of the present invention; Said medical treatment device is set to comprise the chassis; Said chassis comprises first framework that is connected to flexibly on second framework at least, first system unit of said first framework and second system unit in said second framework relative to each other is arranged in the said housing being used for.Said medical treatment device comprises also that by the infusion needle deployment mechanism that can be deployed in the intravital press-button actuated of said shell wherein, in one embodiment, said pin deployment mechanism comprises and is used for said infusion needle is actuated into the intravital spring holder of user.In another embodiment, said pin deployment mechanism comprises that the torsion spring that driven by the finger exercise vertical pole is driven into said infusion needle in the user body being used for.In another embodiment, said pin deployment mechanism comprises: pin carrier and intubate carrier, said pin carrier and said intubate carrier initially are engaged with each other to be used for the using insertion pin that flexible cannula is driven in the user body; And spring member, said spring member is used for when inserting said flexible cannula in the user body, said insertion pin being recalled from user.Similar pin carrier and biosensor carrier also are provided for by means of inserting pin biosensor being inserted in the user body, wherein after inserting said biosensor, said pin are recalled from user.Said medical treatment device comprises that also the specific region that is used on the said top of said housing applies power with the mechanism of manual activation single dose and be used to be deployed as the percutaneous analyte sensors of the blood sugar level of confirming user or the mechanism of certain other physiology indicators.

Still according to this aspect of the present invention, second flexible reservoir is provided for the ccontaining injection volume that is used for carrying to user single dose.Said second reservoir can be set to be communicated with the second infusion cannula fluid, and is preferably used for implementing Drug therapy to the user with type 2 diabetes mellitus.In addition, in this embodiment, said medical treatment device provides the basic speed of infusion of drug to user, and can use with the injection device able to programme such as novopen to be used to provide the Drug therapy of single dose.Said injection device able to programme is preferably programmed by host apparatus, and said host apparatus also calculates the single dose that is used to be expelled to the intravital medicine of user.

Second aspect of the present invention provides the wearable medical treatment device that is used for implementing to user Drug therapy; Said medical treatment device comprises integral housing, and said integral housing comprises flexible upper branch and flexible lower part, wherein; Said housing forms elongated shape; Said elongated shape comprises the length dimension bigger than width dimensions, and comprises that the waist part narrower than said width dimensions, the profile of said housing are designed so that said housing partly locates the narrowest at said waist.The said flexible upper branch of said medical treatment device and said flexible lower part are arrived together along periphery sonic welded separately.

The third aspect of the invention provides the wearable medical treatment device that is used for implementing to user Drug therapy; Said medical treatment device comprises the integral housing with flexible upper branch and flexible lower part; Wherein, said top and said lower part comprise at least one groove that each the outward flange from said top and said lower part extends internally.Said medical treatment device also is included in second groove that the outward flange of position from said top and said lower part each relative with said at least one groove extends internally.Said first groove of said top and said lower part and said second groove limit flex region, and said flex region is separated the first area of said device and the second area of said device.First system unit is included in the said first area and second system unit is included in the said second area.

Another aspect of the present invention provides the wearable medical treatment device that is used for implementing to user Drug therapy; Said medical treatment device comprises the integral housing by flexible upper is divided and flexible lower part constitutes; Wherein, Said housing comprises that central authorities concentrate the portion zone, and a plurality of lobe leaf concentrates portion radially to extend from said central authorities.First system unit of said medical treatment device is included in the first lobe leaf, and second system unit is included in the second lobe leaf.Said first system unit and said second system unit comprise a kind of of the reservoir, biosensor, pin deployment mechanism and the communication receiving/transmission device that are used for carrying the single dose medicine.Said medical treatment device also comprises at least one adhesive pad on the skin attachment side that is attached to said a plurality of lobe leaves.

Last aspect of the present invention provides a kind of method that is used to be provided for implementing to user the flexible and wearable medical treatment device of Drug therapy, and said method is following: preparation comprises that flexible upper is divided and the housing of flexible lower part; In said housing, be provided with and be used for the ccontaining infusion cannula that is communicated with to the reservoir fluid of user medicine to be performed and measure fluid metering mechanism through the injection volume of said infusion cannula enforcement; And form said housing through said flexible upper being divided link to each other along separately periphery with said flexible lower part.Said method is ultrasonically welded to said flexible lower part with said flexible upper branch.

From the detailed description that discloses example embodiment of the present invention with reference to the accompanying drawings, the object of the invention, advantage and outstanding characteristic will become obvious for those skilled in the art.

Description of drawings

To the description of particular example embodiment of the present invention, above-mentioned and other exemplary characteristics and the advantage of specific embodiment of the present invention will become more obvious from reference to the accompanying drawings, in the accompanying drawing:

Fig. 1 is the block diagram that illustrates according to the critical piece of the medical treatment device of example embodiment of the present invention;

Fig. 2 is the diagrammatic sketch according to first example embodiment of the medical treatment device of example embodiment of the present invention;

Fig. 3 A-Fig. 3 C illustrates second example embodiment according to the medical treatment device of example embodiment of the present invention;

Fig. 4 is the diagrammatic sketch according to the 3rd example embodiment of the medical treatment device of example embodiment of the present invention;

Fig. 5 A-Fig. 5 B illustrates the 4th example embodiment according to the medical treatment device of example embodiment of the present invention;

Fig. 5 C-Fig. 5 D illustrates the example embodiment of the adhesive layer that in arbitrary example embodiment of medical treatment device, uses;

Fig. 6 A-6C illustrates the example embodiment of the pump machanism that in arbitrary example embodiment of medical treatment device, uses;

Fig. 6 D-Fig. 6 H illustrates the other example embodiment of pump machanism that in arbitrary example embodiment of medical treatment device, use, shown in Fig. 6 A-Fig. 6 C;

Fig. 7 illustrates another example embodiment of the pump machanism that in arbitrary example embodiment of medical treatment device, uses;

Fig. 8 illustrates the 3rd example embodiment of the pump machanism that in arbitrary example embodiment of medical treatment device, uses;

Fig. 9 illustrates the 4th example embodiment of the pump machanism that in arbitrary example embodiment of medical treatment device, uses;

Figure 10 illustrates the 5th example embodiment of the pump machanism that in arbitrary example embodiment of medical treatment device, uses;

Figure 11 A-Figure 11 E illustrates the example embodiment of the pin deployment mechanism of in arbitrary example embodiment of medical treatment device, using;

Figure 12 A-Figure 12 D illustrates another example embodiment of the pin deployment mechanism of in arbitrary example embodiment of medical treatment device, using;

Figure 12 E-Figure 12 H illustrates the example embodiment of the pick off deployment mechanism that in arbitrary example embodiment of medical treatment device, uses;

Figure 12 I-Figure 12 J illustrates the example embodiment of the manual activation formula cannula deployment mechanism of the carrier that in arbitrary example embodiment of medical treatment device, uses, have user control;

Figure 13-Figure 15 illustrates the additional embodiments according to the medical treatment device of example embodiment of the present invention;

Figure 16 illustrates the additional embodiments according to the delivery device of example embodiment of the present invention.

In institute's drawings attached, should be understood that similar Reference numeral refers to similar element, characteristic and structure.

The specific embodiment

The material of example is provided for and helps complete understanding example embodiment of the present invention in this description, and accompanying drawing is carried out reference.Therefore, those of ordinary skill in the art should be understood that and can carry out various changes and modification and not depart from the scope of the present invention and the spirit of requirement protection example embodiment described herein.And, in order to know and for purpose of brevity, to have omitted description to known function and structure.

Illustrate the common embodiment of medical treatment device 100 among Fig. 1.Medical treatment device 100 is preferably wearable medical treatment device, and it is provided for carrying liquid or gel medicine (preferred but inessential be insulin) through the skin that continuous infusion got into or passed patient, or the other treatment material.Medical treatment device 100 can provide h inf, Intradermal infusion, intramuscular infusion and the intravenous infusion of medicine or material.This known medical treatment device is commonly called " sticking type pump " owing to its wearing or the characteristic that is attached on the user skin.Medical treatment device 100 generally includes housing, the infusion needle deployment mechanism 108 of the container that is used for flexible medicament reservoir 106 or other supply medicines and is used to control through the infusion needle that is arranged on infusion needle deployment mechanism 108 and conducts drugs to user intravital pump machanism 114 or apparatus for metering fluids.Medical treatment device 100 preferably also comprises: other that are used to guide infusion needle deployment mechanism 108 and pump machanism 114 and monitoring and/or control medical devices 100 are preferably operated microprocessor or the controller 116 with system; And power supply 118; The power supply of any known for example; Include but not limited to disposable or chargeable normal cell, capacitor or the co-assigned of for example submitting on July 23rd, 2009 and the U.S. Patent application sequence No.12/458 of common pending trial; Disclosed energy collecting system in 807, whole disclosures of this application are incorporated this paper into through the mode of reference.

An example embodiment of medical treatment device 100 is pre-programmed sticking type pumps.Pre-programmed sticking type pump can be programmed by production firm or healthcare provider, and does not preferably need the other programming of user.Pre-programmed sticking type pump for some patient population (for example recently the type i diabetes patient population of diagnosis, particularly for old or amentia and possibly be difficult to patient population that the sticking type pump is programmed) be ideal.Pre-programmed sticking type pump can comprise simple intelligence being used to provide the basic infusion rates of customization, and this basis infusion rates can whole day changes with coupling sleep and the insulin requirements when clear-headed.Can programme with at one day different time or under various conditions, carry medicine to user to pre-programmed sticking type pump with different speed.Change rate of drug delivery in time and be called as the drug conveying distribution curve at this paper.Pre-programmed sticking type pump also can the single dose of mechanization ground design to allow that manual activation increases, for example 10 units.A kind of form of manual activation needs the persistent period of close electrical contacts (such as one or two instant shut-in) to be used to prolong.Isolating second reservoir can be provided for supplying single dose, and can utilize the same cannula or second intubate that is used for basic infusion.Pre-programmed sticking type pump also can be configured to provide repeatedly daily injection.

In other embodiments of the invention, like what be understood that by those skilled in the art, medical treatment device 100 also can be set to (" simply ") packaging part of programmable fully (" intelligence ") or basic machinery.

Programmable fully " intelligence " sticking type pump is implemented to user maximum degree of accuracy and motility to be provided aspect the speed at the medicine that control is suitable for the user life style, but has increased other cost and complexity to device." intelligence " sticking type pump uses with blood glucose monitor (BGM) and host apparatus (for example individual diabetes monitor (PDM)) usually, with basic infusion rates that customization is provided through closed circuit control and sensing and the single dose that can activate or regulate one day random time." intelligence " sticking type pump for example preferably is configured to via PAN or is communicated with host apparatus via wireless network, and said PAN is like the U.S. Patent application No.12/458 of the common pending trial formerly incorporated into, discloses in 807." intelligence " sticking type pump also can via wired or other directly connect with host apparatus continuously or communication off and on.

" simply " sticking type pump can be provided with seldom or not have system's intelligence and comprise mainly that usually mechanical system is to be used for through the preset basic speed or the single dose of the manual activation basic controlling to infusion of insulin being provided.Than " intelligence " sticking type pump, the cost of " simply " sticking type pump reduces greatly, and this is owing to the more expensive soft copy that need not be used to realize that special sensing, control and communication function are required.

Every kind of sticking type pump packaging part (" intelligence " but pre-programmed and " simply ") be especially effectively with ideal for the user or the user group of particular type.The life style of user, medical condition, financial situation and be suitable for this user for which kind of sticking type pump packaging part that could determine to a great extent of operate medical devices.Below special characteristic and the function of example embodiment of the present invention can in each of the sticking type pump packaging part of above description, implement.Additional embodiments, characteristic and the specific function of sticking type pump used according to the invention can be at the United States Patent(USP) No. that all transfers Insulet company 6; 960; 192 with the open No.2004/0010207 of U.S. Patent application, authorize the United States Patent(USP) No. 6 of people's such as Robert I Connelly co-assigned; 589; 229 and be called in the U.S. Patent application (lawyer's files numbering P-8618 (55579)) of common pending trial of co-assigned of " prolong use medical treatment device " with name that the present invention submits on the same day and find, these documents are incorporated this paper into through the mode of reference.

Illustrate example embodiment among Fig. 2-Fig. 5 according to medical treatment device 100 of the present invention.In the example embodiment of wherein describing each comprises flexible loam cake and flexible lower cover, is 202 and 204 shown in Fig. 2, is 302 and 304 shown in Fig. 3 A and Fig. 3 C, is 402 and 404 shown in Fig. 4, and is being 502 and 504 shown in Fig. 5 A.In example embodiment of the present invention, loam cake and lower cover are formed shell or the housing that is used for medical treatment device 100.In loam cake and the lower cover each preferably is made up of thin flexible polymer, for example polyethylene (PE), polypropylene (PP) or polrvinyl chloride (PVC).These materials are exemplary but not mean restriction, and those skilled in the art should be understood that the material of any appropriate of the thin flexible shell that can use the parts that are used to be provided for medical treatment device 100.Loam cake is preferably similar basically in shape with lower cover, to have the periphery of coupling or approaching coupling.In example embodiment, loam cake and lower cover arrive together along periphery sonic welded separately, to seal the parts of medical treatment device 100 securely.Lower cover preferably is attached to the skin of user via well-known, persistent adhesive layer 210 arbitrarily, wherein adhesive layer 210 is safe for the skin of contact user.When the lower cover of medical treatment device 100 was attached to user, lower cover was in compliance with user and advantageously allow the flexing of whole medical treatment device 100.Loam cake preferably is designed to minimize anti-flexing and the compliance of giving to medical treatment device 100.The housing that is used for medical treatment device 100 of constructing with this mode is extremely thin, flexible and in compliance with the body shape of the uniqueness of each user.Convenience, multifunctionality and comfortableness level that the minimum thickness of medical treatment device 100 and optimum flexibility provide conventional sticking type pump to provide to user.

In example embodiment of the present invention, further preferably the selected shape of loam cake and lower cover is visually attractive to strengthen the whole impression of example medical treatment device 100 for the user and the public.In order to hide the function of medical treatment device 100, loam cake can be designed as and is similar to common binder, can fixation be the colour of skin that is melted into user perhaps.In addition, the loam cake of each embodiment can be decorated design, the art work or the logo of customization, with further intensifier for the vision appeal of user and show the individual character of user, especially when dressing by child.

In example embodiment of the present invention, loam cake can be configured to than lower cover slightly firmly, thicker or more durable, so that the other protection for internal part to be provided.Have optimum flexibility in order to ensure medical treatment device 100, need not to construct the whole surface of loam cake with this mode.For example, as shown in Figure 2, the having more the part of small surface area 203 (it is similar with the loam cake shape) and can construct in the above described manner of loam cake 202 so that other protection to be provided.In another embodiment, the selected zone of loam cake can use this mode to construct, thereby only to the specific part or the parts of medical treatment device 100 other protection is provided.

Fig. 2 and 3 illustrates according to first and second example embodiment of the present invention, that two-dimentional compliance and flexible medical devices 100 are provided.The embodiment that describes among Fig. 2 is an elongated flexible medical treatment device 200, and it has not only realized minimum thickness, is used for the surface area of skin adherence in the increase of user but also provide.The design of flexible loam cake 202 and flexible lower cover 204 provides the compliance that cylindrical shape (the for example arm of user) is increased." waist " 205 of the intermediate section through elongated loam cake and lower cover are set or the size that reduces increase the flexibility and the compliance of the medical treatment device 200 shown in Fig. 2.Medical treatment device 200 has following length dimension: be defined as the longest dimension that extends to the second relative edge 222 of lid from first edge 220 of lid.Medical treatment device 200 has following width dimensions: be defined as the longest dimension that is across to four edge 223 relative with the 3rd edge perpendicular to key dimension and from the 3rd edge 221 of lid.The width of device 200 preferably is designed in intermediate section or " waist " 205 places narrower.In the embodiment shown; Waist segmenting device 200; Thereby form first section 207 and second section 209, the first sections 207 relative and second section 209 preferably with respect to the waist symmetry, make win portion's section and second section have shapes similar and size with first section.

In the example embodiment shown in Fig. 2, being used for the loam cake 202 of medical treatment device 200 and the global shape of lower cover 204 is not specifically to be limited to the shape of being described.Those skilled in the art is to be understood that alternative shape and the relative size with the loam cake that is suitable for using in this embodiment 202 and lower cover 204.For example; In another embodiment; Substitute as illustrated in fig. 2 is being that flexible loam cake and lower cover can comprise at least one the waist portion section along any position of length dimension along the setting midway " waist " 205 of the length dimension of loam cake and lower cover or portion's section of reducing.This waist portion section preferably includes perpendicular to length dimension and less than the size of width dimensions.In this embodiment, loam cake and lower cover need not comprise with respect to symmetric first section of at least one waist portion section and second section or waist portion section even cut apart first section fifty-fifty and second section.The arbitrary shape that it will be understood by those of skill in the art that above flexible loam cake that description limited that provides 202 and lower cover 204 can be suitable for the medical treatment device 100 in first example embodiment.

Like illustrated example embodiment of the present invention among Fig. 2-Fig. 5 the flexible shell of as above discussing that is used for medical treatment device 100 is provided not only; And preferably be utilized in hereinafter further specifically described intravital flexibility of shell and the low profile parts of being positioned at, for example flexible reservoir 106, flexible PCB 216, flexible power supply 118, the flexible electrical conductor between parts and low profile pump machanism 114 and infusion needle deployment mechanism 108.The scope of the profile of medical treatment device 100 on thickness can be from 0.25 inch to 1.25 inches; But preferably be not more than 0.75 inch; This depend on medical treatment device specific function (that is, no matter its be " intelligence ", pre-programmed or " simply ") and choose the specific features that is used for pin deployment mechanism 108 and apparatus for metering fluids 114 and the layout of these parts.Illustrated specific features is not limited to this example embodiment of the present invention and those skilled in the art and should be understood that about utilizing the combination in any and the layout of parts in Fig. 2-Fig. 5 diagram and the example embodiment described each among Fig. 2.

The illustrated flexibility and the medical treatment device 300 of being obedient to form orthogonal basically packaging part among Fig. 3 A-Fig. 3 C, and it is similar to conventional binder, has the surface coverage area of minimizing and the thickness of increase with respect to illustrated embodiment among Fig. 2.Flexible loam cake 302 preferably provides aforesaid optimum flexibility and compliance with flexible lower cover 304.Because the total surface area or the floor space (footprint) of flexible loam cake 302 and flexible lower cover 304 reduce in this embodiment, therefore and nonessential setting " waist " or " intermediate section " that reduce assist compliance or flexibility.But shown in Fig. 3 C, because the surface area of medical treatment device 300 reduces, therefore the parts of some expectations can pile up or be arranged in top each other, thereby cause the thickness of medical treatment device 300 to increase.For overall flexibility and the compliance of keeping medical treatment device 300, as will be below in greater detail, the layout of necessary is parts can not limit the expectation flexing of medical treatment device 300.

Illustrated example embodiment provides example flexible printed circuit board (PCB) 316 and flexible chassis 322 being used to the providing flexibility of particular system component to arrange among Fig. 3 A, and use in aforesaid medical treatment device 100 with the surface area that reduces ideally on flexible printed circuit board (PCB) 316 and flexible chassis 322.The example embodiment of the flexible printed circuit board 316 that in this example embodiment and other example embodiment, uses has been shown among Fig. 3 A.Flexible PCB 316 is revised as fluting, groove or otch 316a and the 316b that comprises along the outer peripheral edges of PCB 316 in this embodiment as shown.Shown in Fig. 3 C, this modification is that PCB 316 provides other degree of flexibility in the position between the rigid system parts preferably, with the flexing of allowing PCB based on the neighbour location of other system parts where necessary.It will be understood by those of skill in the art that the embodiment shown in Fig. 3 A-Fig. 3 C only is provided for explanation, and help to understand the flexibility of enhancing medical treatment device and the notion of compliance.The quantity of otch 316a and 316b, the size of this otch and the layout of otch on PCB 316 are preferably chosen based on the specific quantity and the layout of the parts in the specific embodiment, and are not limited to illustrated example embodiment among Fig. 3 A.

Fig. 3 A and Fig. 3 B illustrate the flexible chassis 322 of in example embodiment of the present invention, using.For valid function medical treatment device 300, preferably reservoir 106, pump machanism 114 and infusion needle deployment mechanism 108 all are set to reasonably adjacent each other at least.But, with the rigidity of these arrangements of components for the non-expectation of the complete buckling that too closely may cause medical treatment device 300.Shown in Fig. 3 B, flexible chassis 322 is set to preferably the pin deployment mechanism 108 and pump machanism 114 of ccontaining at least low profile.Chassis 322 comprises that at least first framework 324 and second framework 326 are held in place corresponding parts being used for each other.Show the 3rd optional framework 328, like what be to be understood that by those skilled in the art, it in certain embodiments can the ccontaining second pin deployment mechanism, percutaneous analyte sensors or biosensor or miscellaneous part arbitrarily.Fig. 3 B illustrate in the corresponding framework 324,326 and 328 each how keep relation relative to each other through the flexible joint 322a that is molded on each in the framework that links to each other.Use the flexible joint 322a on the chassis 322 to make the system unit interconnection be used for corresponding system unit is remained relation relative to each other effectively, the flexibility between the parts of medical treatment device 300 is provided simultaneously.Fig. 3 C is the cross section of medical treatment device 300, illustrates relative localization and the flexing of in example embodiment of the present invention chassis 322 and PCB316.Those skilled in the art should be understood that relative size and the quantity of the framework of flexible interconnect each other are not limited to the diagram among Fig. 3 A-Fig. 3 C but only are provided as example.

Fig. 4 and Fig. 5 A-Fig. 5 B illustrate third and fourth example embodiment of medical treatment device 400, and it provides and has been used for easy other degree of flexibility in compliance with complicated shape.Be similar to the modification of the PCB 316 among Fig. 3, in example embodiment of the present invention, the flexible loam cake of medical treatment device 400 and lower cover can be designed as along periphery separately has fluting, otch or groove 402a and 40b.Quantity, size and the layout of illustrated

groove

402a and 402b only are exemplary among Fig. 4.According to this example embodiment, loam cake and lower cover preferably include at least one the groove 402a that extends internally along the periphery setting of each lid.Said at least one groove preferably but not necessarily is provided with the second similar groove 402b at the opposite edges place of lid.The cooperation groove preferably is divided into

module

403a, 403b and 403c with medical treatment device 400 effectively, and the dimension that other flexibility and compliance is provided to medical treatment device is to be used to allow the complicated bodily form that medical treatment device 400 cosily is arranged in the user health.

Preferably ccontaining at least one system unit of case chamber of describing among Fig. 4 or module, the battery supply in module 403a 118 for example, flexible reservoir 106 and pump machanism 114 and the flexible PCB in module 403c 416 in module 403b.Desirable but non-essential, whole parts will be arranged on the inside of single case chamber or module.As illustrating among Fig. 4, indoor through system unit is arranged on case, the portion that preferably only flexibly connects extends to next case chamber from a case chamber.The greatest flexibility of medical treatment device 400 and the zone of compliance are the positions that independent case chamber engages.Thus, through system unit being arranged in the isolating case chamber, can realize the greatest flexibility and the compliance of medical treatment device 400.

Fig. 5 A and Fig. 5 B illustrate the 4th example embodiment of multidimensional flexible medical device 500, and it also is divided into module or lobe leaf, and even further strengthen the multidimensional compliance of medical treatment device.The central authorities that the loam cake 502 of medical treatment device 500 and lower cover 504 preferably include arbitrary shape and size " concentrate portion " zone 503, and have from what concentrated portion 503 of central authorities radially extended and also be a plurality of modules of arbitrary shape or lobe leaf 505a-505d.Be similar to the example embodiment of describing among Fig. 4, medical treatment device 500 is preferably concentrated ccontaining at least one system unit in each in the portion 503 in lobe leaf 505a-505d and central authorities.Desirable but non-essential, each lobe leaf will combine to be arranged at system unit wherein fully.Since medical treatment device 500 near each position of concentrating portion zone 503 to engage with central authorities among the lobe leaf 505a-505d the most flexible be obedient to most, the portion that therefore under possible situation, preferably only flexibly connects extends to concentrated portion 503 of central authorities from each lobe leaf 505a-505d.In example embodiment of the present invention; Preferably specific features is arranged to and shape is designed to be suitable the integral body of loam cake and lower cover or the shape and the flexing pattern of case chamber; The for example flexible PCB 516 of the shape in the concentrated portion of central authorities that the is suitable for zone 503 shown in Fig. 5 A and Fig. 5 B, and the flexible PCB of describing among Fig. 4 416.

The specific features in the medical treatment device 500 of being contained in shown in Fig. 5 A-Fig. 5 B only are provided as example but not mean restriction.It will be understood by those of skill in the art that in medical treatment device 500 and especially will depend on the purpose function of medical treatment device 500 and change in the layout of indoor concrete parts of independent case and parts.The combination in any that is used to realize the necessary parts of desired function of medical treatment device 500 can advantageously be chosen and be arranged in the flexible shell to realize the greatest flexibility and the compliance of medical treatment device 500.In addition, the shape of loam cake shown in Fig. 5 A and Fig. 5 B 502 and lower cover 504 is not limited to example embodiment of the present invention.It will be understood by those of skill in the art that this device can form flexibility and in compliance with the shape of any appropriate of user health.

Illustrated embodiment provides the other comfort level except the comfortableness that is realized by flexible design to user among Fig. 5 A.Shown in Fig. 5 A, lower cover 504 is preferably through being arranged on radially the skin that adhesive pad 510 on each among the lobe leaf 505a-505d that extends is attached to user.By contrast, common sticking type pump typically is provided with the adhesive layer of the whole surf zone of the attached part of covering shell and user basically.The skin of some user maybe be responsive especially to employed binding agent, and a lot of user usually finds that after the service time of expectation, removing medical treatment device is painful to a certain extent.In addition, the adhesive layer that in common sticking type pump, uses is applying stretching naturally or flexing of the skin that can not allow user in the zone of binding agent.User is often complained the sensation that their skin is pulled and the discomfort of bringing, and this is because the big surf zone of adhesive layer hinders stretching naturally and flexing of user skin.Isolating adhesive pad 510 shown in Fig. 5 A reduces on the skin of user, to apply the total surface area of binding agent; And allow that the skin of user between pad more cosily stretches, and makes any potential skin irritation and the misery relevant with the use of medical treatment device 500 minimize thus.

In other embodiments, the adhesive layer that uses with the example embodiment of medical treatment device can adopt along the periphery of medical treatment device and strengthen flexible pattern (for example crenellation pattern) to be used to allow the freedom of motion in the increase at the interface of the skin of user and example medical treatment device.For example, the pattern 511 that uses with the medical treatment device shown in Fig. 5 can use in example embodiment being used for shown in Fig. 5 C.Like what be to be understood that by those skilled in the art, similar pattern can be used for using with the arbitrary shape of the example medical treatment device of above description.This pattern has reduced with the consciousness of the somatosensory that adheres to the user that accompanies at the interface and through during normal body movement, allowing that flexibility is allowed in the trickle motion of generation on the surface at skin.Adhesive layer is also preferably formed by flexible material or constitutes to allow the trickle stretching, extension of adhesive layer, further strengthens the compliance and the flexibility of medical treatment device thus.Preferably, the freedom of motion that is provided by this binding agent is trickle and is not taken in the motion that the infusion site place causes non-expectation.Yet, in one embodiment, adhere to ring or periphery as the other inflexibility of anchor and can be arranged on infusion site and sentence and be used to prevent motion in this any non-expectation in position.Additional embodiments of the present invention also can comprise having any desired shape or the big or small adhesive layer that increases thickness; Be clipped in elastomer layer or the froth bed 512 between adhesive layer and the medical treatment device perhaps as shown in the sidepiece profile of the medical treatment device 500 in Fig. 5 D, described, with freedom of motion and the flexibility that is used to provide other.Layer 512 thickness preferably is chosen for the overall flexibility of the increase that the example medical treatment device is provided and can when being attached to the skin of user, excessively increase the profile of medical treatment device.Above embodiment is not limited to as directed medical treatment device 500, and can be provided with any above example medical treatment device.

The specific features of describing among Fig. 2-Fig. 5 and the layout of parts are not to mean restriction, and are provided for explaining the notion of various embodiments of the present invention.Being used to of can getting in the combination in any of the parts of discussing below can combining according to the medical treatment device of example embodiment of the present invention and this area realized any miscellaneous part of the specific function of wearable medical treatment device.Like what be to be understood that by those skilled in the art, preferably thin to be used to allow, the flexible and medical treatment device of being obedient to of specific features with arbitrarily favourable layout setting.

In example embodiment of the present invention, controller 116 as shown in fig. 1 is set to be used at least control pump mechanism 114 or apparatus for metering fluids.Controller 116 is preferably ultra low power (ULP) Programmable Logic Controller; It combines necessary processing power and peripheral group to control the drug conveying through pump machanism 114 and to carry out other optional system tasks, for example system or traffic monitoring and with the communication of host apparatus or other external device (ED)s.Controller 116 preferably is embodied as integrated circuit (IC) or " SOC(system on a chip) " (SoC), and it comprises any other circuit, for example is used for and the necessary circuit of host apparatus communication.SoC design usually than they alternate multichip system consumption still less power and have the reliability of lower cost and Geng Gao.Through system-on-a-chip is set, has reduced overall size and the area of electronic unit and simplified the layout of these parts.

In example embodiment of the present invention, IC or SoC preferably are separately positioned on the flexible printed circuit board (PCB) 216,316,416 and 516 shown in Fig. 2-Fig. 5.Flexible PCB is well-known in the art.Structure that these are specific and specification be not in the scope of the present disclosure.Flexible printed circuit board preferably is provided for lead-in wire with various electronic units (for example pump machanism 114, automatically infusion needle mechanism 108 and optional communication receiving/transmission device or blood glucose sensor and other electronic units arbitrarily) and is connected to wiring and supporting on controller 116 and the power supply 118.Flexible PCB preferably has the flexibility same with the example lower cover of medical treatment device in each example embodiment, not limit the overall flex of medical treatment device.

In example embodiment of the present invention, power supply 118 preferably includes one or more thin flexible batteries and/or ultracapacitor.Ultracapacitor and lithium polymer battery flexible, that approach are well-known in the art, and are preferred in example embodiment of the present invention.Power supply 118 can comprise disposable or chargeable power supply.Those skilled in the art should be understood that thin and any known power supply that be preferably flexibility is suitable for being provided as the power supply 118 in the example embodiment of the present invention.In optional embodiment, a plurality of batteries that also can use little rigidity battery or connect through fexible conductor.The embodiment of illustrated power supply 118 is not restrictive among Fig. 2-Fig. 5, but only is provided as the exemplary arrangement that is described in according to the power supply in the medical treatment device of example embodiment of the present invention.In optional embodiment of the present invention, can use individually or use the collection of energy technology that power supply 118 is provided in combination with reference power supply (the U.S. Patent application sequence No.12/458 of the common pending trial of for example formerly incorporating into, 807 in those disclosed).Power supply 118 preferably uses flexible contacts to be connected on the flexible PCB.If be embodied as a plurality of batteries, then each battery all can use flexible contacts to be connected with each other and be preferably spaced apart to promote the optimum flexibility of medical treatment device 100.

In the illustrated example embodiment, reservoir 106 comprises that flexible pouch or capsule are to be used to store medicine or the other treatment material of carrying to user in Fig. 2-Fig. 5.In example embodiment, reservoir 106 offers user in advance with filling.Reservoir 106 is preferably by constituting with the medicine or the flexible polymer of substances compatible that are stored in wherein.The different shape and the size of reservoir 106 have been shown among Fig. 2-Fig. 5.It will be understood by those of skill in the art that certain illustrative is not is restrictive, and the design of reservoir 106 can change according to the specific embodiment of medical treatment device 100.Reservoir 106 preferably is designed to low profile, to obtain the total height/thickness that reduces of medical treatment device 100.In example embodiment, reservoir 106 preferably keeps enough being used for the injection volume of expectation service time of medical treatment device.But in some cases, the medicine of required larger volume possibly be subject to the thin medical treatment device of example.Optional embodiment can comprise and is arranged on the fill port that covers and barrier film being used to allowing that user recharges reservoir 106 (syringe that for example maybe can fill through preparatory filling), thereby the surface area of allowing reservoir 106 reduces.In these embodiment, reservoir 106 also can be filled before using by user.

The common sticking type pump that can get in this area typically comprise as be used for ccontaining medicine reservoir rigid cylinder shape pipe and comprise that the volume displacement that is used to make reservoir medicine is provided the mechanism of pumping mechanism or infusion mechanism, is similar to syringe and plunger or piston.But in example embodiment of the present invention, flexible reservoir 106 has been introduced the unique challenges that is used for to user supply medicine, and this is owing to can not use common technique that medicine is shifted from reservoir.Therefore, example embodiment of the present invention adopt can be from flexible reservoir 106 pumping mechanism or the apparatus for metering fluids of withdrawn fluid or medicine.

The first example pump machanism 614 or the apparatus for metering fluids that are used for using in example embodiment of the present invention comprise " thermal Micropump " shown in Fig. 6 A-Fig. 6 C.Thermal resistance 602 is set to the distal portion near the stream chamber 612 that links to each other with reservoir 106.Thermal resistance 602 produces heat by the electric current that selectivity passes through wherein, and this makes 606 gasifications of thermal expansion fluid, thereby produces bubble and make flexible membrane 604 expansions.Shown in Fig. 6 B, flexible membrane 604 expands in the narrow stream chamber 612, thereby forces medicine to drip in the intubate.When medicine drip with fluidic body portion from the time, thermal expansion fluid 606 cooling and condensing, thus flexible membrane 604 returns to it in the original state shown in Fig. 6 A and Fig. 6 C.When flexible membrane 604 is relaxed to its original state, be inhaled in the narrow stream chamber 612 from the other injection volume of reservoir 106.This embodiment can also comprise that at least one the optional one way stop peturn valve 612 that is arranged in stream chamber 612 is to be used to be controlled at the displacement of the medicine that flows the chamber.First one way stop peturn valve 608 preferably is arranged between reservoir 106 and thermal resistance 602 in the stream chamber 612.This one way stop peturn valve is used for when flexible membrane 604 is expanded as described above, stoping drug flow to get back in the reservoir 106.The second optional one way stop peturn valve 610 can be arranged between thermal resistance 602 and the infusion cannula.Second one way stop peturn valve allows medicine only to flow to user along a direction.When flexible membrane 604 shrank, one way stop peturn valve 610 limit drug were back in the stream chamber 612.Be to be understood that like those skilled in the art each in the optional one way stop peturn valve all can be substituted being used to control the drug conveying to user by electric controlled door or electrically-controlled valve or any other suitable mechanism.Said process can infinitely repeat.The size of the extension frequency of flexible membrane 604 and stream chamber can and be designed to realize the flow rate of medicine to the expectation of user by control.

Make the gasification of thermal expansion fluid and make the agglomerative process of expansion fluid constitute the discharging that is used for injection volume subsequently and aspirate necessary complete expansion and circulate.When the single thermal resistance that uses as Fig. 6 A-Fig. 6 C shown in, transfusion continuously if desired then must quickening circulation cooling/condensation process.Thus, optional fin or heat pipe (not shown) can be set so that thermal expansion is fluidic condenses.As should understand by those skilled in the art, the as known in the art any fin or the heat pipe that are suitable for using in the present invention can be set.

Shown in Fig. 6 D-Fig. 6 H, another embodiment can be provided with a plurality of thermal expansions unit that is arranged in order in the stream chamber 612 and be used to control the mobile peristaltic pump operation of medicine to user with realization.The class of operation of this embodiment is similar to abovely to be discussed about Fig. 6 A-Fig. 6 B, except electric current in this embodiment in order through thermal resistance 602a, 602b and 602c.The electric current that at first provides to thermal resistance 602a causes flexible membrane 604a expansion, thereby forces injection volume towards intubate.Electric current offers the second thermal resistance 602b subsequently in order, and this causes flexible membrane 604b expansion and injection volume further to move towards intubate.Next, the electric current that provides to thermal resistance 602c causes hotting mask 604c expansion and injection volume is discharged in the intubate from stream chamber 612.Through applying electric current in order to each thermal resistance, the mode of extension of hotting mask guarantees that medicine moves along predetermined direction.In the sequence of Fig. 6 E-Fig. 6 H, this process has been shown.When electric current each from thermal resistance removed in order, corresponding thermal expansion fluid condenses and turn back to initial volume allowed that thus other injection volume substitutes the volume that is discharged from.Because a plurality of thermal resistances are provided with in order, therefore when " downstream " thermal resistance charged, the resistance of previous charging began to cool down the thermal expansion fluid and makes the thermal expansion fluid condenses.Thus, the thermal resistance of previous charging has more time to be made the cooling of thermal expansion fluid and condenses, and allows that thus successive expansion circulation is to be used to implement the continuous-flow of medicine to user.

Those skilled in the art should be understood that the hot expanded film 604 shown in Fig. 6 A-Fig. 6 H need not be integral or be contained in the stream chamber 612 with stream chamber 612.Maybe further preferably hot expanded film be set to and flow that chamber 612 is separated and adjacent, with " compressing " stream chamber when the expansion.Compressing stream chamber 612 with this mode acts on so that medicine flows to the intubate of infusion site from reservoir 106 in a similar fashion.

Unidirectional electrical cervical orifice of uterus 611 is depicted as and is used to control medicine flowing to user.In Fig. 6 D, electronic gate 611 is depicted as to be controlled at and is used for preventing that drug flow from getting into the state in the intubate.Shown in Fig. 6 E-Fig. 6 G, when when thermal resistance 602a-602c provides electric current in order, electronic gate 611 is controlled to be allows medicine flowing to intubate.Shown in Fig. 6 H, in case injection volume is discharged in the intubate, electronic gate 611 just can be controlled to be the injection volume that prevents to be discharged and got back in the stream chamber 612 by suction.As should understand by those skilled in the art, electronic gate 611 can be replaced by with Fig. 6 A-Fig. 6 C in similar setting one way stop peturn valve or be used to control medicine to mobile other devices arbitrarily of user.

Illustrate the second example pump machanism 714 that uses with the above similar concept among Fig. 7.In this embodiment, keep the chamber 712 interim ccontaining injection volume of waiting to flow to user, the for example insulins of single dose.Injection volume gets into through one way stop peturn valve 708 from reservoir 106 and keeps in the chamber 712.When electric current is applied to 702 last times of thermal resistance, thermal expansion fluid 706 is heated and expands, thereby towards keeping chamber 712 to drive barrier films 704, makes injection volume displacement and force medicine to pass through second one way stop peturn valve 710 to arrive delivery cannula in keeping chamber 712 thus.The one-way function of the check-valves 708 of reservoir side prevents that medicine is compelled to return in the reservoir 106.In case thermal expansion fluid 706 cools off and condenses, the power that is applied by spring 715 is enough to drive barrier film 704 away from maintenance chamber 712, thereby increases the volume that keeps chamber 712, and this is drawn to other injection volume and keeps in the chamber 712 from reservoir 106.Cannula side check-valves 710 prevents that the medicine in the intubate from being got back to by suction and keeps in the chamber 712.As should understand by those skilled in the art, the electric controlled door that one way stop peturn valve 708 and 710 can replace with shown in Fig. 6 D-Fig. 6 H and Fig. 9 perhaps is used to control medicine mobile any other suitable devices to user.

Above process can infinitely repeat, and may be controlled to the flow rate of medicine to the expectation of user is provided.Equal the injection volume of displacement from keep chamber 712 to the injection volume that user is carried.Keep the capacity of chamber 712 and can design and be controlled to be the infusion rates that the expectation of medicine is provided to user by the shift amount that thermal expansion fluid 706 causes.In Fig. 7 in the variant embodiment of illustrated system, thermal resistance and thermal expansion fluid can replace with solenoid shaft as piston to be controlled at the fluid displacement that keeps in the chamber 712.

Fig. 8 illustrates the 3rd example pump machanism 814 that uses with above-mentioned similar concept.This embodiment utilizes corrugated tube fluid chamber 812, and it is expanded when drawing medicine, and compression is to discharge medicine from the chamber.The expansion of bellows chamber 812 and compression are driven by thermal resistance 802 and thermal expansion fluid 806.When applying electric current, thermal resistance 802 heat hot expansion fluids 806, thermal expansion fluid 806 gasifies, significantly expands and applies power to flexible membrane 804.The power that applies to flexible membrane 804 causes the film expansion, is driven into bellows chamber 812 in the compressive state thus and through one way stop peturn valve 810 discharge of medicament volumes.When electric current removed from thermal resistance 801, thermal expansion fluid 806 condensed and the power of abated effect on flexible membrane 804.When flexible membrane 804 was relaxed to its original state, as illustrating among Fig. 8, bellows chamber 812 was drawn in the extended mode downwards, thereby from reservoir 106, drew other injection volume with when needed to the user supply.

Illustrate another example pump machanism 914 that is suitable for using in the present invention among Fig. 9.This embodiment uses Belleville spring 904 or other suitable spring mechanisms (for example punching press leaf spring, chuck or flexing part) to apply power to flexible reservoir 106.Force the medicine of reservoir 106 to get in the stream chamber 912 by the Belleville spring applied pressure.Stop pressurized drug to be infused in the user body through electric controlled door or metering valve 910 (the for example two-way fluid valve of solenoid control).Metering valve 910 is preferably controlled to allow the flow rate of medicine to the expectation of user by controller 116.As should understand by those skilled in the art, can be suitable for this embodiment of the present invention with any metering valve or the goalkeeper of the flow rate of allowing expectation by electric control, for example magnetic fluid (ferrofluidic) door or valve.

As shown in Figure 10, be used for comprising the simple membrane pump of from the flexible reservoir (not shown), drawing medicine at the other example pump machanism 1014 that example embodiment of the present invention is used.Membrane pump shown in Figure 10 can be set to the MEMS nanometer pump that obtains from Debiotech company, and generally includes a series of check-

valves

1008 and 1010 and piezoelectric diaphragm 1004 mobile with the medicine that is used for realizing being contained in reservoir or other materials.Piezoelectric diaphragm 1004 be arranged in the flow channel 1012 and when applying voltage, change size and shape to deformed state.Diaphragm 1004 can be controlled to be from undeformed state and switch to deformed state times without number.This perseveration is drawn medicines and is discharged medicines through second one way stop peturn valve 1010 to pass through first one way stop peturn valve 1008 from reservoir 106 as the function of pump.

Also can use other optional pumping mechanism and apparatus for metering fluids in other embodiments of the invention.Those skilled in the art people will find, reasonably be to adopt the pump machanism of any known that is suitable for wearable medical treatment device to be used for to user dispense liquid medicament/medicine.Regardless of selected mechanism, preferably pump machanism be compact, lightweight and low profile can increase the size and the thickness of medical treatment device necessarily.

The example embodiment of illustrated medical treatment device comprises low profile pin deployment mechanism 108 among Fig. 2-Fig. 5, and it can be manually or automatically activates being used for infusion cannula is inserted in the user body.The infusion cannula that is used for using in example embodiment of the present invention can comprise have be used for infusion of drug to the infusion needle of the intravital side ports of user, or can comprise alternatively by means of inserting pin and insert the intravital flexible cannula of user.In addition, flexible cannula can be provided with the prong head and to allow flexible cannula inserted in the user body, eliminates the demand for isolating insertion pin thus.Syringe needle can be hard with respect to axle alternatively.Other other example embodiment can comprise intrinsic flexibility, the draw point or be provided preferably with the high flexibility torsion spring of attachment sharp needle of slotting.Slotted needle and torsion of each of the embodiment is also preferably used encapsulated in sealed fluid flow chamber therein Teflon or Vialon

sheath or coating.Name submitting on the same day is called in the U.S. Patent application of owning together of common pending trial of " prolong and use medical treatment device " (lawyer's files numbering P-8618 (55579)) can find more detailed description, and the full content of this application is incorporated this paper into through the mode of reference.Certainly the fluid encapsulation material of any appropriate can be used in the formation sheath.Fluting draw point and torsion spring embodiment are the flexible comfortablenesses to be used to increase, and are provided for inserting rigidity required in the skin of user or post intensity.The fluting draw point is because fluting forms flexibility, and advantageously need not have the syringe needle that separates but can be for having the single body of sharp needle.Torsion spring preferably includes the attached separation sharp needle in the skin that thrusts user.Another example embodiment of the present invention is utilized microneedle array, those that for example in the infusion device of the nano injection that is provided by Debioech company (Nanoject), use.Like what be understood that by those skilled in the art, other suitable infusion mechanisms can use in example embodiment of the present invention arbitrarily.

Figure 11 A-Figure 11 E and Figure 12 A-Figure 12 D illustrate the example embodiment of the pin deployment mechanism 108 that is used for using in example embodiment of the present invention.Figure 11 A illustrates and is used for infusion needle or intubate are inserted the intravital manual activation formula of user chuck 1102.The power that applies to button 1101 forces chuck 1102 to fade to concave position from raised position, thereby infusion cannula is driven in the user body.Second example embodiment of illustrated pin deployment mechanism 108 is used for infusion cannula is driven into the intravital torsion spring 1105 of user among Figure 11 B.In this embodiment, infusion cannula comprises round pin 1104.Round pin 1104 is subject to the circular path that is guided by torsion spring 1105.Before activating, pin is remained in the ready position through the stop arm 1106 that is attached on the finger exercise vertical pole 1103.In this embodiment, user is through applying power with stop arm 1106 relative ends and activate pin and dispose to finger exercise vertical pole 1103.When user when stick 1103 applies downward power, the stop arm of stick 1106 pivots away from blocking position and allows that torsion spring 1105 is driven into infusion needle in the user body.

Figure 11 C-Figure 11 E illustrates another example embodiment that is used for using in the present invention, and it is particularly suitable for the fluting draw point and the torsion spring infusion needle of flexibility discussed above.Shown in Figure 11 C, flexible infusion needle 1122 is attached to pin carrier 1124.Pin carrier 1124 is by keeping latch member 1126 to remain in the ready position of withdrawal, keeps latch member 1126 to prevent that pin carrier 1124 from moving along direction of insertion.Infusion needle is disposed and can manually or automatically be activated so that keep latch member 1126 to be shifted from blocking position.Shown in Figure 11 D, when keeping breech lock 1126 to activated, compression spring 1128 is along direction of insertion driving needle carrier 1124.After in infusion needle 1122 is inserted the user bodies, the distal movement of pin carrier 1124 receives the chassis 1130 that holds the pin deployment mechanism or the obstruction of housing.Figure 11 D and Figure 11 E illustrate the pin deployment mechanism with guide thimble 1132 of Figure 11 C, and guide thimble 1132 is used for the insertion angle of flexible infusion needle 1122 with expectation is directed in the user body.In addition, guide thimble 1132 is buckled with opposing during disposing or the deflection of other non-expectations for flexible needles 1122 provides other integrated level.Like what from Figure 11 D and Figure 11 E, be to be understood that, guide thimble 1132 can be configured in the medical treatment device to allow the deployment of carrying out a plurality of directions with respect to the motion of pin carrier 1124.Thus, the use of guide thimble 1132 is allowed infusion needle 1122 is deployed in the skin in example embodiment, simultaneously through allowing that carrier is parallel to skin movements the pin deployment mechanism is minimized the influence of the overall profile of medical treatment device.

Figure 12 A-Figure 12 D illustrates with above and describes the example embodiment of similar pin deployment mechanism about Figure 11 C, by means of inserting pin flexible cannula is driven in the user body automatically or manually being used for.Shown in Figure 12 A, rigidity is inserted pin 1202 and is arranged in the inner chamber of flexible cannula 1204, and wherein sharp needle is extended from the end of flexible cannula 1204.Inserting pin and intubate is remained in the position relative to each other by pin carrier 1206 and intubate carrier 1208.Pin carrier 1206 and intubate carrier 1208 be by keeping latch member 1212 to remain in the ready position of withdrawal, keeps latch member 1212 to stop that intubate carrier 1208 moves along direction of insertion.Pin is disposed and can manually or automatically be activated so that keep latch member 1212 from blocking position, to be shifted.Shown in Figure 12 B, when keeping breech lock 1212 to activated, the first compression spring 1210 drives intubate carrier 1208 along direction of insertion.Pin carrier 1206 engages with intubate carrier 1208, and the insertion campaign of intubate carrier 1208 is driven into pin 1202 in the user body thus.After pin 1202 and intubate 1204 were inserted in the user bodies, the distal movement of intubate carrier 1208 received the chassis that holds the pin deployment mechanism or the obstruction of housing.Shown in Figure 12 C, in the interrupted position of the distal movement of intubate carrier, intubate carrier 1208 breaks away from pin carrier 1206.Shown in Figure 12 D, in this position, the second compression spring 1211 drives the pin carrier 1206 that breaks away from along proximal direction, and pin 1202 is recalled in the user body, and intubate 1204 keeps inserting simultaneously.

In example embodiment discussed above, shown in Fig. 2, Fig. 4 and Fig. 5 A, user can apply power through the actuation button on the outer surface that is arranged on loam cake, finger exercise vertical pole or other breech lock holding devices and manually activate the insertion of intubate.In addition, because the thin flexible characteristic of the loam cake of the medical treatment device 100 in each embodiment discussed above, the manual activation device can be arranged in the housing and preferably apply power through the specific region on the outer surface of loam cake and activated.

Above-mentioned pin deployment mechanism only is provided as example embodiment.Embodiment shown in Figure 11 and Figure 12 also can utilize motor-driven parts or other electric components but not breech lock and spring mechanism are deployed to infusion cannula in the user body being used for.It will be understood by those of skill in the art that any pin deployment mechanism that can get in the art can implement in optional embodiment of the present invention.Preferably, selected pin mechanism comprises better simply structure and is the flexible medical device of low profile to obtain to approach.

In addition; As should understand by those skilled in the art; Any above-mentioned pin deployment mechanism can somewhat modified being used to dispose percutaneous analyte sensors or biosensor (for example blood glucose sensor), use with optional embodiment at the medical treatment device 100 that is used for realizing the continuous blood sugar monitoring.For example, the embodiment described in Figure 12 A-Figure 12 D can be provided for inserting biosensor 1222, and this biosensor 1222 is arranged at the inside of trocar sheath or pin 1224 shown in Figure 12 E-Figure 12 H.After disposing biosensor 1222, trocar sheath 1224 can be withdrawn, thereby biosensor 1222 is exposed in the subcutaneous tissue of user.Shown in Figure 12 E, biosensor 1222 is remained in the position relative to each other by pin carrier 1225 and biosensor carrier 1223 with pin 1224.Pin carrier 1225 and biosensor carrier 1223 be by keeping latch member 1212 to remain in the ready position of withdrawal, wherein keeps latch member 1212 to stop that biosensor 1223 moves along direction of insertion.Pick off is disposed and can manually or automatically be activated so that keep latch member 1212 from blocking position, to be shifted.Certainly, should be understood that this deployment can be caused by manual deployment, perhaps electronically actuated via the suitable instruction that receives from BGM or host apparatus.Shown in Figure 12 F, when keeping breech lock 1212 to activated, the first compression spring 1226 is along direction of insertion driving needle carrier 1225 and biosensor carrier 1223.After biosensor 1222 and pin 1224 inserted in the user bodies, the distal movement of biosensor carrier 1223 received the chassis that holds the pin deployment mechanism or the obstruction of housing.Shown in Figure 12 G, in the interrupted position of the distal movement of biosensor carrier 1223, pin carrier 1225 breaks away from biosensor carrier 1223.Shown in Figure 12 H, in this position, the second compression spring 1227 drives the pin carrier 1225 that breaks away from along proximal direction, and pin 1224 is recalled from user, and biosensor 1222 keeps inserting simultaneously.

Figure 12 I-Figure 12 J illustrates and is used for interior another deployment mechanism in pin and intubate of using at medical treatment device according to an embodiment of the invention.The pin deployment can be by user control but not through previous mechanism's triggering of describing.That is, carrier 1225 is biased in the retracted position by compression spring 1228.Figure 12 I shows the device that is in the retracted position, makes pin 1229 not outstanding from the chassis with intubate 1230.Carrier 1225 comprises can be by the approaching manual actuator 1231 of user.When user makes manual actuator when the direction of arrow " A " moves with the power that is enough to overcome the spring biasing, carrier 1225 moves with pin 1229 and the direction of intubate 1230 along arrow " A ".Carrier 1225 also comprises the finger breech lock 1232 that matches with the maintenance surface 1233 that keeps on the breech lock 1234.When carrier 1232 when the direction of arrow " A " moves, finger breech lock 1232 and keep the interference between the surface 1233 to cause keeping the direction displacement of breech lock 1234 along arrow " B ".Finger breech lock 1232 moves through each with the feasible finger of the shape that keeps surface 1233 breech lock and keeps surface 1233, and carrier 1225 is prevented from along retracted orientation toward moved back.When carrier when the direction of arrow " A " moves, pin and intubate are outstanding and get in the skin surface of user from the chassis.What cantilevered kept that breech lock 1234 can be along arrow " B " is directed downwards flexing to release loose carrier 1225 and to make pin and cannula retracted.Like what be to be understood that, can adopt the layout that keeps breech lock 1234 downward flexings to release any appropriate of loose carrier 1225 through making by those skilled in the art.This layout can comprise by user via the manual movement of the device on the outside that is arranged on the chassis or via the suitable instruction on PDM automatically electronics release pine.

Combination and layout like illustrated above system unit among Fig. 2-Fig. 5 are not to mean restriction.It will be understood by those of skill in the art that any above-mentioned parts can be as make up and arrange to be used to be embodied as the certain drugs treatment of each user customization requiredly in any above-mentioned example embodiment.The other example embodiment of medical treatment device 100 that illustrates the combination that utilizes above-mentioned parts among Figure 13-Figure 15 is to be used to realize the certain drugs treatment.

Figure 13 illustrates the specific embodiment that is used for providing through the single infusion cannula that is arranged on single pin deployment mechanism 108 medical treatment device of two kinds of Drug therapys.

Reservoir

106a and 106b are set to be communicated with single infusion cannula fluid and controlled to be used for controlling the drug flow from each reservoir by single pumping mechanism 114 and optional valve system.Based on the quantity of the parts among this embodiment, the loam cake of medical treatment device suitably is designed to comprise three lobe leaves 1301,1302 and 1303 of concentrating portion zone 1304 radially to extend from central authorities.Lobe leaf 1301 preferably holds pin deployment mechanism 108 and

lobe leaf

1302 and 1303 preferably holds

reservoir

106a and 106b respectively.

Figure 14 illustrates another embodiment that is used for providing through first and second infusion cannula that provided by the first and second

pin deployment mechanism

108a and 108b the medical treatment device of Drug therapy.Each infusion cannula manually or automatically activates as described above.In one embodiment, flexible loam cake can provide to button near to be used for manual activation each pin deployment mechanism 108 and 108b.Each infusion cannula can be connected to be used to supply two kinds of Drug therapys when needed with himself

reservoir

106a or 106b fluid.Alternatively, single reservoir can be shared by each infusion cannula, allows thus where necessary in support or second infusion cannula.

Figure 15 illustrates another embodiment that is used for providing through single infusion cannula three kinds of Drug therapys.The first reservoir 106a and the second reservoir 106b are depicted as through optional valve and are connected on the single pumping mechanism 114, to be used for controlling the drug flow from each reservoir.In addition, as shown in, the 3rd reservoir 106c can directly be set to infusion cannula to be used for the time allowing manual medicine single dose in expectation.Because thin, the flexible characteristic of the loam cake of medical treatment device, user can apply power and the manual activation single dose through the specific region to loam cake.The specific region is preferably adjacent with reservoir 106c to be used for remaining on the medicine supply that single dose is provided.Reservoir 106c preferably is arranged in the specific lobe leaf (1503) of device, thereby user can be pushed lobe leaf 1503 to implement single dose.Power by user applies can be discharged injection volume to offer user through infusion cannula from reservoir.Like what be to be understood that by those skilled in the art, alternatively, the power that is applied by user can make electrical contacts closed, and this automatically activates the injection of single dose via electric pump mechanism and controller.In another embodiment, like above similar providing, medical treatment device can be set to only through one or more infusion cannula the single dose that is contained in one or more medicines in one or more reservoirs is provided.

Like what should understand by those skilled in the art, some in various embodiments that the additional embodiments shown in Figure 13-Figure 15 only illustrates the present invention is allowed and the layout.The quantity of the particular combination of above-mentioned parts, particularly reservoir and be stored in wherein medicine and can be chosen for and be used for the medical conditions that is suitable for user and the particular treatment of other factors being provided to user.Particularly, the example medical treatment device can initially be made as through the injection of only implementing a plurality of daily injections or only single kind or multiple medicine and treat type ii diabetes.When the disease state of user develops into the increase level of glucagon, have another combination of parts or the similar medical treatment device of layout and can be used for more effective treatment.

In addition, the characteristic of above-mentioned example embodiment can be arranged in the various application occasions similarly and be not limited to above open.Device other skin surfaces, wearable can utilize above characteristic and technology to be used for through the greatest flexibility and the compliance of wearable device maximum comfortableness and convenience being provided arbitrarily.Except the disclosed insulin sticking type of this paper pump installation; Through above disclosed wearable medical treatment device the other drug treatment can be provided ideally also; For example be used to treat rheumatoid arthritis or infusion human growth hormone; Particularly for child or old man, for them, thin lightweight medical treatment device 100 is ideal.

In any example embodiment of above description, medical treatment device also can use with delivery device 1600 able to programme (the for example novopen able to programme shown in Figure 16).In a preferred embodiment, but wearable medical treatment device is configured to only provide pre-programmed or the programmable basic injection rate that presets, and delivery device 1600 wherein able to programme is provided for the necessary single dose of infusion.Though some embodiment of wearable medical treatment device discussed above can provide single dose, some user possibly be more suitable for and more be ready to use the injection device of being familiar with shown in Figure 16.In addition, for some user, the Drug therapy that is provided separately by the novopen device can be an efficacious therapy.Common mechanical novopen injection device typically needs the interaction of user to set the desired amount that is used to inject exactly.Conventional mechanical pin generally includes and possibly be difficult to see or be difficult to the accurately low dose of scale of setting.Thus, in example embodiment of the present invention, novopen device 1600 able to programme has eliminated because the potential probability of the consumption mistake that user can not the proper operation device be caused.

In one embodiment of the invention, when not in use, other devices that delivery device 1600 preferably keeps being attached to individual diabetes management device (PDM) 1602, blood sugar monitoring instrument (BGM) or is used to calculate single dose.When user is controlled PDM 1602 with calculating single dose demand; PDM calculates dosage by the blood sugar level of basic speed infusion history or user, and this dosage directly is programmed in the delivery device 1600 and does not need any other calculating, setting or the adjusting of user.PDM 1602 can also comprise sense mechanism or the other system that is used for confirming blood sugar level, and this blood sugar level is used to calculate the single dose of the expectation that is used for user.This example embodiment of the present invention has reduced the required step number of infusion and reduced can not proper operation common mechanical novopen and the consumption mistake that causes by user.

Delivery device 1600 in the example embodiment preferably includes interchangeable insulin box and can be drum forms, is similar to the novopen that can get usually.The dosage mechanical parts that typically is arranged in the top of common novopen preferably replaces with the flexing circuit that twines around the internal diameter of pen container.Rechargeable battery can be arranged on the centrage of the inner pen container of flexible circuit.Interchangeable insulin box is arranged in the lower part of pen, and Micropump is arranged between an insulin box and the pin.Perhaps, linear actuators can be arranged in that flexible circuit is inner to be aimed at the insulin bottle.Linear actuators applies power driving the plunger in the bottle, thereby causes the single dose that equates with the shifted volume of plunger motion.Very little linear actuators can be obtained and this purpose can be advantageously used in.An example is Squiggle linear actuators of being made by New Scale technology company.Preferably separate with replacing insulin box with the lower part on the top of pen, and the electrical connection for Micropump is provided when re-assemblying.At every turn be attached to 1602 last times of PDM when delivery device 1600, the rechargeable battery in the conveyer device 1600 just can charge, and the infusion history or the blood glucose history that are stored in the pen can automatically be loaded among the PDM 1602.

Example embodiment of the present invention can provide delivery device 1600, its have as describe in the U. S. application 12/458,807 of the common pending trial of formerly incorporating into, be used for via the necessary low-cost parts of PAN communication.This embodiment allows the continuous communication between disclosed " intelligence " wearable medical treatment device in delivery device 1600 and PDM1602 or above example embodiment.The health physical connection of " as long as intelligence " medical treatment device or PDM and delivery device 1600 and user, when calculating single dose, " intelligence " medical treatment device or PDM just can carry out automated programming to delivery device 1600 at every turn.Hold biosensor or can also provide the single dose demand to programme automatically by this device to delivery device 1600 with blood sugar level based on user with " intelligence " wearable medical treatment device of biosensor communication.In addition, when when user is implemented single dose, delivery device 1600 can upgrade via PAN, PDM or " intelligence " medical treatment device automatically at every turn.Above embodiment provides a kind of low cost, intelligentized device, the function of its wearable medical treatment device of disclosed example more than being easy to use and for a lot of user that need insulinize, can further strengthening among the familiar embodiment.

Although illustrate and described the present invention with reference to specific illustrative embodiment, the present invention should not be limited to these example embodiment but only limit to accompanying claims and their equivalent.Should be understood that those skilled in the art can change or revises and do not depart from scope of the present invention and spirit example embodiment.

Claims

1. wearable medical treatment device that is used for implementing Drug therapy to user, said medical treatment device comprises:

Integral housing, said integral housing comprises: be used for the flexible reservoir of the supply of ccontaining medicine, said flexible reservoir be used for being communicated with to the infusion cannula fluid of user said drug conveying; And apparatus for metering fluids, said apparatus for metering fluids is used to measure from said reservoir through the drug conveying of said infusion cannula to said user;

Said housing comprises flexible upper branch and flexible lower part.

2. medical treatment device as claimed in claim 1, wherein, said flexible upper is divided and said flexible lower part is arrived together along their periphery sonic welded separately.

3. medical treatment device as claimed in claim 1, wherein, the thickness of said integral housing is from 0.25 inch to 1.25 inches.

4. medical treatment device as claimed in claim 1, wherein, the thickness of said integral housing is for being not more than about 0.75 inch.

5. medical treatment device as claimed in claim 1, wherein, said flexible upper is divided and said flexible lower part is made up of flexible polymer.

6. medical treatment device as claimed in claim 1, wherein, the said flexible lower part of said housing is attached to the skin of user with adhesive layer.

7. medical treatment device as claimed in claim 6 also comprises elastomer layer or froth bed between the said lower part that is arranged on said adhesive layer and said housing.

8. medical treatment device as claimed in claim 1, wherein, said apparatus for metering fluids comprises at least one thermal resistance.

9. medical treatment device as claimed in claim 8; Wherein, Each said thermal resistance is arranged in the thermal expansion fluid of being sealed by flexible membrane partly; Wherein, the fluidic heating of each said thermal expansion causes the expansion of said flexible membrane, thereby causes the displacement of said medicine and through infusion needle said medicine is actuated in the said user body.

10. medical treatment device as claimed in claim 9; Wherein, A plurality of thermal resistances are provided with in order and charge in order to realize the drug flow to said user, and each in wherein said a plurality of thermal resistances all is arranged in the thermal expansion fluid of being sealed by flexible membrane partly.

11. medical treatment device as claimed in claim 9, wherein, said apparatus for metering fluids also comprises and is used to promote drug flow at least one one way stop peturn valve to said user.

12. medical treatment device as claimed in claim 9, wherein, said apparatus for metering fluids also comprises and is used to promote at least one electric controlled door or the electrically-controlled valve of drug flow to said user.

13. medical treatment device as claimed in claim 1, wherein, said apparatus for metering fluids comprises: a kind of in Belleville spring washer, punching press leaf spring, chuck or the flexing part, and it is used for exerting pressure to said reservoir; And metering valve.

14. medical treatment device as claimed in claim 1, wherein, said housing also comprises flexible PCB, is electrically connected with controller to be used for making at least said fluid metering mechanism.

15. medical treatment device as claimed in claim 14, wherein, said flexible PCB also comprises at least one groove that extends internally from the outward flange of said circuit board.

16. medical treatment device as claimed in claim 1; Wherein, Said housing also comprises the chassis; Said chassis comprises first framework that is connected to flexibly on second framework at least, first system unit of said first framework and second system unit in said second framework relative to each other is arranged in the said housing being used for.

17. medical treatment device as claimed in claim 1, wherein, said housing also comprises by the infusion needle deployment mechanism that can be deployed in the intravital press-button actuated of said shell.

18. medical treatment device as claimed in claim 17, wherein, said pin deployment mechanism comprises and is used for said infusion needle is driven into the intravital spring holder of said user.

19. medical treatment device as claimed in claim 17, wherein, said pin deployment mechanism comprises and is used for said infusion needle is driven into the intravital torsion spring of said user.

20. medical treatment device as claimed in claim 19, wherein, said torsion spring activates being used for through the finger exercise vertical pole said infusion needle is driven in the said user body.

21. medical treatment device as claimed in claim 17, wherein, said pin deployment mechanism comprises pin carrier and intubate carrier, and said pin carrier and said intubate carrier initial engagement each other are driven into flexible cannula in the said user body to be used for use insertion pin.

22. medical treatment device as claimed in claim 17, wherein, said pin deployment mechanism comprises and is used for flexible needles or cannula assembly are driven into the intravital single carrier of said user.

23. medical treatment device as claimed in claim 17; Wherein, Said pin deployment mechanism comprises pin carrier and biosensor carrier, and said pin carrier and said biosensor carrier initial engagement each other are driven into biosensor in the said user body to be used for use insertion pin.

24. medical treatment device as claimed in claim 21, wherein, said pin deployment mechanism also comprises spring member, when said spring member is used in said flexible cannula inserts said user body said insertion pin is recalled from said user.

25. medical treatment device as claimed in claim 1, wherein, said housing also comprises and is used for applying the mechanism of power with the manual activation single dose through the specific region on the said top of said housing.

26. medical treatment device as claimed in claim 1, wherein, said housing also comprises the mechanism of the analyte sensors that is used to dispose the blood sugar level that is used for definite user.

27. medical treatment device as claimed in claim 1, wherein, said housing also comprises second flexible reservoir of the medicine that is used for the ccontaining certain volume that is used for carrying to the single dose of user.

28. medical treatment device as claimed in claim 27, wherein, said second flexible reservoir is communicated with the second infusion cannula fluid.

29. medical treatment device as claimed in claim 27, wherein, said medical treatment device is used for the user with type ii diabetes is implemented Drug therapy.

30. medical treatment device as claimed in claim 1, wherein, said fluid metering mechanism provides pre-programmed drug conveying distribution curve to user.

31. medical treatment device as claimed in claim 1, wherein, the ccontaining medicine supply that is used to be infused into the intravital basic speed of user of said flexible reservoir.

32. medical treatment device as claimed in claim 31, wherein, said medical treatment device uses to be used for providing to user the Drug therapy of single dose with injection device able to programme.

33. medical treatment device as claimed in claim 32; Wherein, Said injection device able to programme can be programmed by host apparatus, and said host apparatus calculates and is used for to the single dose of said user injection and the dosage that said injection device is programmed and calculated to implement.

34. medical treatment device as claimed in claim 33, wherein, said injection device able to programme is a novopen able to programme.

35. a wearable medical treatment device that is used for implementing to user Drug therapy, said medical treatment device comprises:

Integral housing; Said integral housing comprises flexible upper branch and flexible lower part; Wherein, said housing forms elongated shape, and said elongated shape comprises the length dimension bigger than width dimensions; And comprise that the waist part narrower than width dimensions, the profile of said housing are designed so that said housing partly locates the narrowest at said waist.

36. medical treatment device as claimed in claim 35, wherein, said flexible upper is divided and said flexible lower part is arrived together along their periphery sonic welded separately.

37. a wearable medical treatment device that is used for implementing to user Drug therapy, said medical treatment device comprises:

Integral housing, said integral housing comprise that flexible upper is divided and flexible lower part, and wherein, said top and said lower part comprise at least one groove that each the outward flange from said top and said lower part extends internally.

38. medical treatment device as claimed in claim 37 also is included in second groove that the outward flange of position from said top and said lower part each relative with said at least one groove extends internally.

39. medical treatment device as claimed in claim 38, wherein, said first groove and said second groove limit the first area of said device and the separated flex region of second area of said device.

40. medical treatment device as claimed in claim 39, wherein, first system unit is included in the said first area and second system unit is included in the said second area.

41. a wearable medical treatment device that is used for implementing to user Drug therapy, said medical treatment device comprises:

Integral housing, said integral housing comprise flexible upper branch and flexible lower part, and wherein, said housing comprises that having central authorities concentrates the portion zone, and a plurality of lobe leaf concentrates portion radially to extend from said central authorities.

42. medical treatment device as claimed in claim 41, wherein, first system unit is included in the first lobe leaf and second system unit is included in the second lobe leaf.

43. medical treatment device as claimed in claim 42, wherein, said first system unit and said second system unit are chosen from the group that comprises the reservoir, biosensor, pin deployment mechanism and the communication receiving/transmission device that are used for carrying drug dose.

44. medical treatment device as claimed in claim 42, wherein, said first system unit and said second system unit comprise first flexible reservoir and second flexible reservoir respectively.

45. medical treatment device as claimed in claim 41 also comprises at least one adhesive pad on the skin attachment side that is attached to said a plurality of lobe leaves.

46. a method that is provided for implementing to user the flexible and wearable medical treatment device of Drug therapy, said method comprises:

Preparation comprises that flexible upper is divided and the housing of flexible lower part;

In said housing, be provided with and the fluid metering mechanism that is used for the ccontaining infusion cannula that is communicated with to the reservoir fluid of user medicine to be performed and measures the medicine of the certain volume through said infusion cannula enforcement; And

Form said housing through said flexible upper being divided link to each other along separately periphery with said flexible lower part.

47. method as claimed in claim 46 wherein, forms step through said flexible upper branch sonic welded is carried out to said flexible lower part.